Actively Recruiting
A Multicentre Prospective Longitudinal Observational Study to Evaluate Biomarkers in Moderate to Severe Ulcerative Colitis Patients Treated With Different Targeted Therapies
Led by Central Hospital, Nancy, France · Updated on 2025-05-06
95
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Ulcerative colitis (UC) is a long-lasting inflammatory bowel disease that mainly affects adults aged 30 to 40. It causes recurring inflammation in the colon and can lead to disability and lower quality of life. Researchers are studying how to better predict which treatments will work for each patient by identifying new biomarkers in blood, stool, and tissue samples. This study focuses on moderate to severe UC and aims to personalize treatment by understanding early responses to therapy. Participants in this observational study have moderate to severe UC and are starting treatment with biological or small molecule therapies such as anti-TNF, anti-IL12/23, anti-integrin agents, or JAK inhibitors. The study involves collecting samples through blood draws, stool collection, and endoscopic biopsies to analyze biomarkers. These procedures occur alongside regular care and assessments to monitor disease activity and treatment response. During the study, researchers will track clinical responses, remission rates, mucosal healing, and symptom improvements at multiple time points up to 52 weeks. They will also observe disease progression, patient-reported outcomes, and long-term complications up to 104 weeks. Participants will undergo standard evaluations including endoscopy and laboratory tests as part of their care and study assessments. The study expects to help guide more personalized treatment choices based on biomarker findings.
CONDITIONS
Brief Title
A Study to Evaluate Biomarkers in Moderate to Severe Ulcerative Colitis (UC) Patients Treated With Different Targeted Therapies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients 18 years of age or older at the time of signing the informed consent form
- Established diagnosis of ulcerative colitis with a minimum disease duration of 3 months
- Moderate to severe active ulcerative colitis defined by a Mayo Score of 6 or higher
- Moderate to severe active ulcerative colitis defined by an endoscopy score of 2 or higher
- Indication to start any biological or small molecule agent such as anti-TNF, anti-IL12/23, anti-integrin, or JAK inhibitors
- Stable dose of corticosteroids (20 mg prednisone or less) for at least 3 weeks prior to baseline if treated with corticosteroids
- Indication for endoscopy to assess disease activity according to standard care and guidelines
- Ability to comply with study procedures
- Affiliated to or beneficiary of a social security plan
- Informed about study organization and able to sign informed consent form
You will not qualify if you...
- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or radiation colitis
- Absolute contraindications to endoscopy or complications during previous endoscopy
- Bleeding disorders
- Indication for surgery for ulcerative colitis
- Use of rectal topical therapy (enemas or suppositories) within 2 weeks prior to baseline
- Treatment with more than 20 mg prednisone within 3 weeks prior to baseline
- Anemia with hemoglobin less than 10 g/dl at baseline
- Any other condition that makes study participation unsuitable as assessed by the investigator
- Pregnancy, breastfeeding, minors who are non-emancipated, adults under legal protection or unable to consent
- Persons deprived of liberty by judicial or administrative decision or under psychiatric care as specified by law
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline and up to 52 weeks
Participants undergo procedures including endoscopic biopsies, blood sampling, and stool sampling to assess disease activity and biomarkers according to standard care.
Multiple assessments including baseline and follow-up visits up to week 52
Duration - Up to 104 weeks
Participants are observed over time to monitor clinical response, remission, mucosal healing, disease progression, and complications.
Regular follow-up visits up to week 104
Trial Site Locations
Total: 1 location
1
Central Hospital
Nancy, Lorraine, France, 54500
Actively Recruiting
Research Team
L
Laurent MD Peyrin-Biroulet, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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